2 Years After Germany's Regulation For Digital Health Apps, What Can We Learn?

June 10, 2022
DNA sequencing

At the end of 2019, the Digital Healthcare Act (Digitales Versorgungsgesetz, DVG) introduced a dedicated pathway enabling reimbursement of digital health offerings in Germany, bringing more transparency into the approval process for manufacturers, physicians, and patients. Although its scope is narrow and the bar for inclusion high, many consider the DVG a breakthrough that allowed Germany to advance from a relatively low level of healthcare digitization (among developed countries) into a role model position. Since the first digital health application (digitale Gesundheitsanwendung, DiGA) was approved for reimbursement in September 2020, 28 DiGAs have now been approved for reimbursement, either provisionally or permanently. As more apps await approval and more prospective medtech and biotech companies eye the German digital market, lessons from current DiGAs could help shape how clinical design and eventual application for reimbursement are approached. In this analysis, we take a closer look at DiGA applications to date to draw conclusions for manufacturers.